NCT07296237 Beyond Survival: Addressing Gynecological and Sexual Health in Women After Radiotherapy for Anal Cancer
| NCT ID | NCT07296237 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aarhus University Hospital |
| Condition | Anal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-11-13 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2025-11-13 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to learn how radiotherapy for anal cancer affects the vaginal and sexual health of women after treatment. The study will also look at whether the radiation dose to the vagina is linked to the level of vaginal problems. The main questions this study aims to answer are: * How many women develop moderate or severe narrowing of the vagina after radiotherapy? * Is there a link between the radiation dose and vaginal problems? * How do vaginal changes affect sexual health and daily life? * What care and support do women receive, and how satisfied are they with this support? Participants are women aged 18 years or older who were treated with chemotherapy and radiotherapy for anal cancer and are 6 to 36 months after treatment. Participants will: Have a gynaecological examination to check the vagina for changes such as narrowing, stiffness, bleeding, or scarring Complete online questionnaires about quality of life and sexual health Answer questions about use of vaginal dilators, hormone treatment, and sexual counselling Allow researchers to analyse their radiotherapy scans to measure how much radiation the vagina received Some participants will also take part in a telephone interview about their experience with guidance and support after treatment The study will include about 80 participants across three Danish hospitals. About 20 participants will take part in the interview part of the study. The results from this study may help improve how doctors and nurses prevent, detect, and treat vaginal and sexual problems after radiotherapy for anal cancer. This may lead to better support and quality of life for future patients.
Eligibility Criteria
Inclusion Criteria: * Women aged 18 years or older * Diagnosed with anal cancer * Treated with chemoradiotherapy with curative intent * Between 6 and 36 months since completion of radiotherapy * Able and willing to give written informed consent Exclusion Criteria: * Previous pelvic radiotherapy for another disease * Treated with electron beam radiotherapy * Unable to speak or understand Danish
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07296237 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Anal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07296237 currently recruiting?
Yes, NCT07296237 is actively recruiting participants. Contact the research team at johste@oncology.au.dk for enrollment information.
Where is the NCT07296237 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Herlev, Denmark, Vejle, Denmark.
Who is sponsoring the NCT07296237 clinical trial?
NCT07296237 is sponsored by Aarhus University Hospital. The trial plans to enroll 80 participants.
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